1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Inspection Record
Abich Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The maintenance of records was inadequate.
3Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
4Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
5Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
6Stability and storage
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media.
7Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-02-05. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
